Physical training improves quality of life (QOL) in non-hepatic diseases. It is possible that the same effect happens in patients with cirrhosis and portal hypertension. Hepatic encephalopathy may also benefit from physical activity by increasing ammonia metabolism. The intention of this study is to assess if patients can improve their QOL and hepatic encephalopathy during a physical training program, and to address its safety.

Patients randomized to the physical training program and diet intervention

Other: Physical training

A program of exercising under strict surveillance, with endurance and coordination maneuvers

Other Names:

Physical training

Exercise

Muscle ammonia metabolism

Other: Diet intervention

Energy intake tailored to basal metabolism and level of physical activity. Protein and sodium intake will be adjusted to 1.2-1.5 g/kg/d, and 1.5-2 g/d of salt, respectively. The latter will be adjusted only in those patients presenting ascites and/or edema

Other Names:

Nutritional therapy

Diet

Active Comparator: Control - No encephalopathy

Patients not allocated to exercise program, but undergoing diet intervention

Other: Diet intervention

Energy intake tailored to basal metabolism and level of physical activity. Protein and sodium intake will be adjusted to 1.2-1.5 g/kg/d, and 1.5-2 g/d of salt, respectively. The latter will be adjusted only in those patients presenting ascites and/or edema

Other Names:

Nutritional therapy

Diet

Experimental: Physical training - Early encephalopathy

Patients with early hepatic encephalopathy (minimal or clinical grade 1-2) randomized to the physical training program

Other: Physical training

A program of exercising under strict surveillance, with endurance and coordination maneuvers

Other Names:

Physical training

Exercise

Muscle ammonia metabolism

Other: Diet intervention

Energy intake tailored to basal metabolism and level of physical activity. Protein and sodium intake will be adjusted to 1.2-1.5 g/kg/d, and 1.5-2 g/d of salt, respectively. The latter will be adjusted only in those patients presenting ascites and/or edema

Other Names:

Nutritional therapy

Diet

Active Comparator: Control - Early encephalopathy

Patients with early hepatic encephalopathy (minimal or clinical grades 1-2) not allocated to the physical training program, but undergoing diet intervention

Other: Diet intervention

Energy intake tailored to basal metabolism and level of physical activity. Protein and sodium intake will be adjusted to 1.2-1.5 g/kg/d, and 1.5-2 g/d of salt, respectively. The latter will be adjusted only in those patients presenting ascites and/or edema

Other Names:

Nutritional therapy

Diet

Detailed Description:

Patients with cirrhosis and portal hypertension experience a marked deterioration in health-related quality of life (QOL), as it has been shown with the use of questionnaires such as Short-Form-36 (SF-36) and Chronic Liver Disease Questionnaire (CLDQ). The deterioration in QOL is progressively accentuated as liver failure advances. There is a positive association between the level of physical activity and the sense of QOL, and physical training programs have proved to be useful in improving QOL in cardiovascular and pulmonary diseases, and in conditions affecting cognition. Thereby, it is hypothesized that a physical training program may improve QOL and hepatic encephalopathy in patients with cirrhosis and portal hypertension. Data supporting physical activity as a way to improve hepatic encephalopathy derives from experimental models showing that skeletal muscle is able to remove blood ammonia, presumably by inducing the enzyme glutamine synthetase. However, it is uncertain whether such a program is safe, or if it can lead to an increase in portal hypertension and progression of the disease.

Eligibility

Ages Eligible for Study:

18 Years to 70 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Biopsy-proven or clinically evident cirrhosis

Able to perform exercise

Exclusion Criteria:

Overt hepatic encephalopathy grades 3 or 4

Cardiovascular complications (pulmonary hypertension, heart failure)

Diabetes mellitus and microangiopathic complications, or under treatment with insulin

Renal failure

Portal hypertension with high risk for variceal bleeding

Hepatocellular carcinoma

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00517738